Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exo, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
196 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 | 196 | 0 |
| K242359 | Strain AI (SAI001) | Exo, Inc. | 2024-11-20 | 103 | 0 |
| K232501 | AI Platform (AIP001) | Exo, Inc. | 2023-11-17 | 92 | 0 |
| K230497 | Bladder AI (AIBV01) | Exo, Inc. | 2023-06-22 | 118 | 0 |
| K831801 | HEMOCLAV VENOUS CATHETER | Exo, Inc. | 1983-07-07 | 34 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda